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A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Study acronym: Clarity AD
StatusActive, Not Recruiting
PhasePhase 3
SponsorEisai Inc.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion moved earlier from Jun 30, 2029 to Dec 31, 2026 Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 3 of 8 entries · Study sites revised (247) · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 8 entries
    • Study sites revised (247)
    • Publications: details revised at 9 of 9 entries
  2. Eligibility criteria expanded, about 63 words Secondary endpoints: 5 to 8v19 Show 1 more changeShow less
    • Secondary endpoints: 5 to 8

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: May 26, 2027 to Jun 30, 2029 Primary endpoints: 3 to 4 · Interventions: Drug: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) to Lecanemab IV (Drug), Lecanemab SC (Drug), Placebo (Drug) · Eligibility criteria expanded, about 16 words · 3 morev18 Show 6 more changesShow less
    • Primary endpoints: 3 to 4
    • Interventions: Drug: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) to Lecanemab IV (Drug), Lecanemab SC (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 6 words
    • Study arms: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv17
  5. Primary and study completion dates: Sep 15, 2027 to May 26, 2027 Interventions: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) to Drug: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) · Study arms: 7 to 8v16 Show 2 more changesShow less
    • Interventions: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) to Drug: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug)
    • Study arms: 7 to 8
Show 14 earlier versionsHide 14 earlier versions
  1. Interventions: Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) to Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) Eligibility criteria revised · Study arms: 5 to 7v15 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Interventions: Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) to Lecanemab (Drug), Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug) Eligibility criteria expanded, about 38 words · Study arms: 4 to 5v14 Show 2 more changesShow less
    • Eligibility criteria expanded, about 38 words
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria shortened, about 6 wordsv13 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion dates: Sep 15, 2025 to Sep 15, 2027 Eligibility criteria shortened, about 2 wordsv12 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoints revised (3) Secondary endpoints: 2 to 4v11 Show 1 more changeShow less
    • Secondary endpoints: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Sep 8, 2022 to Sep 15, 2025 Primary endpoints revised (3) · Enrollment target: estimated 1766 to confirmed 1906 · Completion date: Aug 29, 2024 to Sep 15, 2025 · 5 morev10 Show 8 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: estimated 1766 to confirmed 1906
    • Completion date: Aug 29, 2024 to Sep 15, 2025
    • Interventions: Lecanemab (Drug), Placebo (Drug) to Lecanemab (Drug), Lecanemab (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 76 words
    • Secondary endpoints: 3 to 2
    • Study description expanded, about 6 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  7. Trial status: Recruiting to Active, Not Recruiting Study sites: 259 to 247v9 Show 1 more changeShow less
    • Study sites: 259 to 247
  8. Primary completion date: Jun 30, 2022 to Sep 8, 2022v8
  9. Enrollment target: 1566 to 1766 Study sites: 250 to 259 · Eligibility criteria expanded, about 115 wordsv7 Show 2 more changesShow less
    • Study sites: 250 to 259
    • Eligibility criteria expanded, about 115 words

    See this version in full on ClinicalTrials.gov ↗

  10. Interventions: BAN2401 (Drug), Placebo (Drug) to Lecanemab (Drug), Placebo (Drug) Eligibility criteria revised · Study title revisedv6 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  11. Primary completion date: Feb 24, 2022 to Jun 30, 2022 Completion date: Jul 3, 2024 to Aug 29, 2024 · Eligibility criteria expanded, about 17 words · Study description expanded, about 33 wordsv5 Show 3 more changesShow less
    • Completion date: Jul 3, 2024 to Aug 29, 2024
    • Eligibility criteria expanded, about 17 words
    • Study description expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  12. Primary endpoints revised (3) Study sites: 154 to 250 · Completion date: Mar 7, 2024 to Jul 3, 2024 · Eligibility criteria expanded, about 789 wordsv4 Show 3 more changesShow less
    • Study sites: 154 to 250
    • Completion date: Mar 7, 2024 to Jul 3, 2024
    • Eligibility criteria expanded, about 789 words

    See this version in full on ClinicalTrials.gov ↗

  13. Primary completion date: Mar 7, 2024 to Feb 24, 2022 Primary endpoints: 4 to 3 · Study sites: 1 to 154 · Start date changed from estimate of Mar 29, 2019 to Mar 27, 2019 · 2 morev3 Show 5 more changesShow less
    • Primary endpoints: 4 to 3
    • Study sites: 1 to 154
    • Start date changed from estimate of Mar 29, 2019 to Mar 27, 2019
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  14. Enrollment target: 1556 to 1566 Collaborators expanded, about 1 wordv2 Show 1 more changeShow less
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biogen
92 trials monitored
See 7 trials at risk
Alzheimer's Disease
1,152 trials monitored
See 60 trials at risk
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.
Trial Details
NCT Number NCT03887455
Lead Sponsor Eisai Inc.
Collaborators: Biogen
Conditions Early Alzheimer's Disease
Enrollment 1,906 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov